Senior Supplier Quality Engineer(SQE)

Company : Katalyst HealthCares & Life Sciences

Location : San Jose, CA, 95199

Posted Date : 1 October 2025

Job Type : Other

Category : Industrial Engineering

Occupation : Quality Engineer

Job Details

Job Description:
As a Senior Supplier Quality Engineer, you have a unique impact on the quality and reliability of our devices. You will work with cross-functional teams to maintain and improve the Quality System within the requirements of FDA's Quality System Regulation (QSR), ISO 13485 (ISO) and EU MDR. You will build a partnership culture with the supply chain with transparency, coaching, and adapting to our continuous improvement philosophy. Being detail and solution oriented, proactive, and self-managed will assist in the success of this position.
Responsibilities:

Conduct supplier assessments and audits to evaluate their capabilities, processes, and quality management systems to meet our regulatory requirements.
ssist in the selection and qualification of new suppliers based on established procedures.
Develop periodic reports on supplier performance (scorecards). Establish and maintain periodic reviews with suppliers on their performance, and improvement plan.
Maintain detailed records of supplier audits, quality performance, and corrective action plans.
Report on supplier quality performance during cross-functional meetings and provide recommendations for improvement.
Create supplier quality reports, including analysis on defect trends, root causes, and long-term resolutions.
Ensure effective implementation of corrective actions and track results to ensure continuous improvement.
Lead resolution of supplier related non-conformances using problem solving tools (8D, Fishbone, 5 WHY's, etc.).
In-depth understanding of manufacturing processes, including machining, fabrication, casting, injection moulding, and assembly processes.
bility to assess the quality impact of supplier manufacturing changes and deviations.
Must have excellent problem-solving abilities using systemic, logical, and sequential approaches and provide technical oversight for issue/problem resolution activities.
Comprehensive knowledge of TMV's, process and product validations (i.e., IQ, OQ, PQ). Ability to independently execute supplier process validation.
dvanced knowledge of quality management tools, including, but not limited to (SPC, FMEA, MSA, DOE, and Quality Systems).
Support continuous product and process improvement through detailed failure analysis for nonconformance's, and investigates, develop, and implements effective and compliant solutions for product or process corrections, retrospective, and remediation action plans, and for corrective and preventive actions.

Requirements:

Bachelor's degree preferably in an engineering or scientific discipline.
5+ years' experience working in manufacturing of finished medical device or related industry.
Working knowledge of the FDA Quality System Regulation, ISO 13485, ISO 14971, and the EU Medical Device Directive.
Lead auditor credentials for QSR, ISO, or MD SAP, and EU MDR are desired.
(Cognitive Skills) Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
Knowledge of probability, statistical quality control and design of experiments, Minitab proficiency preferred.
Knowledge of geometric design and tolerance (GD&T) and gage design tolerance preferred.